Table of Contents

Blood Lactate Monitoring System
Introduction....................................................................................................3
Contents of the System.................................................................................4
Meter Components .......................................................................................6
EDGE Blood Lactate Test Strip.....................................................................8
Using Your Meter for the First Time.............................................................10
• Setting the Clock.............................................................................10
• Turning ON/OFF Beep Sound........................................................12
• Changing Unit of Measurement......................................................13
• Coding the Meter............................................................................14
• Checking the System......................................................................17
• Monitor Checker Method................................................................17
• Control Solution Method.................................................................19
Performing a Blood Lactate Test.................................................................23
• Obtaining a Drop of Blood..............................................................23
• How to Perform a Test ....................................................................24
• Understanding the Test Result ........................................................27
THE EDGE
Table of Contents
1
THE EDGE
Blood Lactate Monitoring System
2
Using the Meter Memory.............................................................................28
Setting Time After First Use.........................................................................29
Caring for the Meter....................................................................................31
•Precautions......................................................................................31
•Storage............................................................................................31
•Changing the Battery.......................................................................32
•Cleaning the Meter..........................................................................33
Solving Problems........................................................................................34
Product Warranty.........................................................................................38
Specifications..............................................................................................39
Symbols Used in this Mannal......................................................................41
Supplies.......................................................................................................42
THE EDGE Blood Lactate Monitoring System provides you with important
information concerning individual metabolism and oxygen debt. The system is
especially designed for an application by in a number of disorders including:
liver disease, heart disease, diabetes mellitus, muscular dystrophy, thiamine
deficiency, neoplastic disorders. Regardless an application can also be effected
by medical specialists in application can also be effected by medical specialist
in medial diagnostic. Here it is possible to use measurement results as decision
support for following medical treatments of the patient because of the skilled
and qualified result evaluation (In Vitro). THE EDGE Blood Lactate Monitoring
System is designed for both personal use and professional use.
Blood Lactate Monitoring System
Thank you for choosing THE EDGE Blood Lactate Monitoring System.
All of the information that will be needed to use and maintain THE EDGE Blood
Lactate Monitoring System is included in this manual. Please read it carefully
before using the system.
THE EDGE
Introduction
3
THE EDGE
Blood Lactate Monitoring System
4
Contents of the System
THE EDGE system may include the following items.
•
•
•
•
•
THE EDGE Blood Lactate Meter 3V Lithium Coin Cell Battery (CR 2032) Monitor Checker EDGE Blood Lactate Test Strips Code Card •
•
•
•
•
User’s Guide
Log Book
Wallet
Puncturer
Lancets (28G)
In addition to the above items, THE EDGE Lactate control solution may also be
purchased to check the system (P.20). Please contact your nearest authorised
dealer when needed.
THE EDGE
Code Card Port
Enter Button
Battery
Compartment
Shift Button
Test Strip Holder
FRONT
BACK
Blood Lactate Monitoring System
Code Card
Display
Monitor
Checker
5
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Blood Lactate Monitoring System
6
Meter Components
LCD Screen������������������������������Displays information that guides users through testing
and setup, and shows test result and error messages.
Shift Button &������������������������Turn meter on and off. Control selection and steps of
Enter Button
userprogrammable setup in Function Mode.
Test Strip Holder������������������Insertion site for test strip. Located on the bottom at
front side of the meter.
Battery Compartment��������Holds one 3V Lithium coin cell battery to power the
system. Located on the backside of the meter.
Monitor Checker�������������������Used to confirm that THE EDGE meter is functioning
properly.
Blood Lactate Monitoring System
Code Card����������������������������������Codes the meter for the test strips that have the same
code when inserted into the code card port. Insert the
code card with the code number facing up. One code
card is packaged with each box of Test Strips.
THE EDGE
Code Card Port����������������������Insertion site for code card. Located at top of the
backside of the meter.
7
THE EDGE
Blood Lactate Monitoring System
8
EDGE Blood Lactate Test Strip
Contact Points������������������������Sense the position and orientation of the test strip.
Test Strip Handle������������������The area to be held when inserting the test strip.
Reaction Zone�������������������������The area where the blood sample or control solution
is applied.
Contact Points
Test Strip Handle
Reaction Zone (Apply Blood Here)
IMPORTANT:
EDGE Blood Lactate Test Strips come in a moisture proof and light protected
bottle . Because the test strips are sensitive to moisture and light, it is
important that the bottle is kept well sealed before use. Replace the cap of
THE EDGE
the test strip bottle tightly after a test strip is taken out of the bottle. DO NOT
leave any test strips outside the bottle while not in use. When performing a
blood test, insert the test strip with the contact points up and towards the
meter, then apply blood " " For additional information on the EDGE Blood
.
LactateTest Strips, refer to the package insert
Blood Lactate Monitoring System
9
THE EDGE
Blood Lactate Monitoring System
10
Using Your Meter for the First Time
Setting the Clock
Step 1: Press any key to turn on the meter.
Step 2: A clock symbol " " will flash on screen. Press "ENTER" button to
enter setup of the date & time in the order of Year-Month-Day and then
Hour-Minute.
Step 3: The pre-set Year will flash on screen. Press "SHIFT" button to scroll
through the years and press "ENTER" button to confirm.
Press and hold on the "SHIFT" button for quick searching of the years.
THE EDGE meter provides calendar years from 2005 to 2099.
Step 4: The pre-set Month will flash on screen. Press "SHIFT" button to scroll
through the months and press "ENTER" button to confirm. Press and
hold on the "SHIFT" button for quick searching of the month.
Step 7: The pre-set Minute will flash on screen. Press "SHIFT" button to scroll
through the minutes and press "ENTER" button to confirm. Press and
hold on the "SHIFT" button for quick searching of the minute.
Step 8: Press the two buttons on the meter simultaneously to return to the
Blood Test Mode during date or time setting.
Blood Lactate Monitoring System
Step 6: The pre-set Hour will flash on screen. THE EDGE meter uses am/pm
time clock. Press "SHIFT" button to scroll through the hours and press
"ENTER" button to confirm. Press and hold on the "SHIFT" button for
quick searching of the hour.
THE EDGE
Step 5: The pre-set Day will flash on screen. Press "SHIFT" button to scroll
through the days and press "ENTER" button to confirm.
Press and hold on the "SHIFT"button for quick searching of the day.
11
THE EDGE
Blood Lactate Monitoring System
12
Turning ON/OFF Beep Sound
Step 1: Press any key to turn on the meter.
Step 2: The LCD screen will show a 4-digit code number, unit of measurement,
date & time, and a symbol of test strip.
Step 3: Press the two buttons on the meter simultaneously.
Step 4: A symbol of head " " will flash on screen. Press "SHIFT" button to skip
this selection.
Step 5: A symbol of cable " " will flash on screen. Press "SHIFT" button to
skip this selection.
Step 6: A symbol of speaker " " will flash on screen. Press "ENTER" button
to enter setup. Press "SHIFT" button to turn ON/OFF beep sound. The
"Speaker" with wave ahead of the speaker means ON; the "Speaker"
without wave means OFF.
Step 7: Press the two buttons on the meter simultaneously to return to the
Blood Test Mode.
Blood Lactate Monitoring System
Step 1: Press any key to turn on the meter.
Step 2: The LCD screen shows at the Blood Test Mode that contains a 4-digit
code number (
Please refer to P.14 "Coding the Meter"), unit of
measurement, date & time, and a symbol of test strip.
Step 3: Press the two buttons on the meter simultaneously to enter the
Function Mode.
Step 4: A symbol of head " " will flash on screen. Press "SHIFT" button to skip
this selection.
Step 5: A symbol of cable " " will flash on screen. Press "SHIFT" button to
skip this selection.
Step 6: A symbol of speaker " " will flash on screen. Press "SHIFT" button to
skip this selection.
Step 7: A symbol of clock " " will flash on screen. Press "SHIFT" to skip this
selection.
Step 8: The pre-set unit of measurement will flash on screen. Press "ENTER"
button to enter setup. Press "SHIFT" button to change between mg/
dL and mmol/L, and press the "ENTER" button to confirm. Then, the
display will return to the Blood Test Mode.
THE EDGE
Changing Unit of Measurement
13
THE EDGE
Blood Lactate Monitoring System
14
Coding the Meter
IMPORTANT:
After setting the date and time for the first time, the current CODE will appear
on the screen when the meter is turned on each time. Verify that the CODE
displayed on screen matches the CODE number on the package of test strip
before each use of the meter. The CODE needs to be set only once for each
package of test strips. The meter will memorize the CODE until it is changed.
The CODE number on the meter screen not matching the CODE number on
the test strip package will create an inaccurate blood lactate test result.
To code the meter with a code card, follow these steps.
Step 1: Locate the code card in the package of test strip.
Step 3: Insert the code card with the code number facing up firmly and
completely into the code card port on the backside of the meter.
Step 4: Press any button to power on the meter.
Blood Lactate Monitoring System
Step 2: Verify that the code number on the code card matches the code
number on the test strip package.
THE EDGE
NOTE:
There is a code card packaged in each box of test strips. The code card is
designed specifically for use with the test strips in that particular package.The
code card should have same code number as that indicated on the package of
the test strips.
15
THE EDGE
Blood Lactate Monitoring System
16
Step 5: A 4-digit code number will
display on the meter screen.
Verify the code number on
the screen with that on the
code card and that on the test
strip package.
The four numbers on the
code card, meter, and test
strip bottle should match.
The code number displayed on the meter should
match the code number on the gray code card and
on the front of the test strip package.
NOTE:
Recoding needs to be done when opening a new package of test strips with a
different code number.
Monitor Checker Method:
It is recommended that THE EDGE meter is checked using this method when
the meter is new and when the performance of the system needs to be
confirmed.
To check the meter using a monitor checker, perform the following steps.
Step 1: Insert the monitor checker into the test strip holder (when the meter is
either turned on or off) , THE EDGE meter will now perform a series of
self-fest.
Blood Lactate Monitoring System
There are two ways to check performance of THE EDGE Blood Lactate
Meter. These checks are simple and very important to ensure accurate lactate
readings.
1.The Monitor Checker confirms the meter is operating properly.
2.The control solutions confirm the meter and test strips are working together
properly.
THE EDGE
Checking the System
17
THE EDGE
Blood Lactate Monitoring System
18
Step 2:The meter display screen will show "OK" when self-testing is complete.
Remove the monitor checker from the test strip holder and the screen
will then display "Ctrl".
Step 3:Press "ENTER" button to exit checking the meter.
NOTE:
If the screen displays “nt OK”, repeat the test. If “nt OK” continues to appear,
contact the authorized dealer.
When to perform a control solution test • whenever there is doubt that the meter or the test strips are not working
properly.
• if the meter has been dropped, stored below -20°C (-4°F) or above 50°C (122°F)
, or stored in humidity levels above 85%.
• if the test strip bottle has been left open or has been exposed to
and/or light or
temperatures below 4°C (39.2°F) or above 30°C (86°F)
humidity levels above 85%.
• if the readings appear to be abnormally high or low.
Blood Lactate Monitoring System
Please ask your authorized distributor to purchase THE EDGE Lactate Control
Solution.
The purpose of the control solution check is to validate the performance of
THE EDGE Blood Lactate Analyzer using a standard solution with a known
concentration range of lactate. A control solution test that falls within the
acceptable range indicates the user’s technique is appropriate and both the
meter and the test strip are functioning properly.
THE EDGE
Control Solution Method:
19
THE EDGE
Blood Lactate Monitoring System
20
IMPORTANT:
• The acceptable range for the control solution is listed on the package of test
strips.
• Use only THE EDGE Lactate Control Solution and EDGE Blood Lactate Test
Strips.
• Always check the expiration date for both THE EDGE Lactate Control
Solution and EDGE Blood Lactate Test Strips. DO NOT use if expired.
• If a control solution test is not within the expected range that is printed
on the test strip package, DO NOT use the system. Repeat the test until
a control solution test performs within the expected range. If the results
continue falling outside the expected range, call the authorized dealer.
• DO NOT touch the test area with the tip containing control solution.
• DO NOT apply a second drop of control solution to the test strip.
• DO NOT smear the control solution with the tip containing control solution.
• Please refer to your control solution's package insert for additional
information.
THE EDGE
To check the meter using control solution,
perform the following steps.
Only apply the control
solution to the reaction
zone on top of test strip.
Blood Lactate Monitoring System
Step 1: Perform Monitor Checker method up
to Step 2 (see P.17, Monitor Checker
Method) and verify the code number
on screen is the same with the code
number printed on the bottle.
Step 2: The screen will display "Ctrl", and then
insert an EDGE Blood Lactate Test
Strip.
Step 3: The screen will flash a symbol of liquid
drop ” ” instructing applying the control
solution.
DO NOT apply control
solution from the edge
of test strip.
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THE EDGE
Blood Lactate Monitoring System
22
Step 4: Apply a drop of control solution on the yellow reaction zone in the
middle top of the test strip.
Step 5: The screen will show timing bars “----“ that flash and then gradually
diminish for countdown.
Step 6: After the timing bars disappear (in approximately 45 seconds), the
screen will show test result. Compare the reading on the screen to the
range indicated on the test strip package. Remove the test strip.
Step 7:Remove and properly discard the used test strip.
Step 8:The screen will display at blood test mode.
The test result of control solution will not be stored in memory.
NOTE:
If the test result is not within the expected range, repeat testing of
the control solution until the result falls within the range.If the results continue
falling outside the expected range, please call your authorized dealer.
Obtaining a Drop of Blood
Step 1: Wash hands with soap and warm water and dry thoroughly. Warm water
stimulates blood flow to the fingers making it easier to obtain a sample.
Step 2: Hang the arm down at the side for 10 to 15 seconds massage through
the wrist, palm, and then finger. This can stimulate the blood flow to the
finger more quickly.
Step 3: Hold the lancing device (puncture) or lancet against the side of the
finger and lance the finger. Follow manufacturer’s instruction for how
the lancing device (puncture) or lancet should be used.
Blood Lactate Monitoring System
IMPORTANT:
When performing a blood lactate test, use a new sterile lancet every time. If
alcohol wipes are used to cleanse the fingers, make sure the area is dry before
the blood sample is obtained.
THE EDGE
Performing a Blood Lactate Test
23
THE EDGE
Blood Lactate Monitoring System
24
TIP:
To avoid soreness, select a site on the side of your fingertips. To avoid
calluses, choose a different site each time for obtaining the blood sample.
How to Perform a Test
IMPORTANT:
Always use EDGE Blood Lactate Test Strips with THE EDGE Blood Lactate
Meter.
Step 1: Follow the instruction on page 14 "Coding the Meter".
NOTE:
If the screen shows "Code ---", or if the CODE number on the
screen does not match the CODE number on the test strip
package, refer to page 14 for details of (re)coding the meter.
Step 2:The meter will self-test the environment temperature.
If the temperature is out of range, the screen will
show a symbol of thermometer
.
If the temperature is within the testing range of 10°C to 40°C
(50°F
to 104°F), the screen will show a symbol of blood ” ” indicating to apply
blood.
Step 3: Obtain a drop of blood and apply
OR
the blood either to the absorbent
area at the curved edge of the
test strip or the yellow reaction
zone on the top of the test strip.
Gently message your hand and finger toward the
puncture site to form a drop of blood (approximately: ).
Do not "milk” or squeeze around the puncture site.
Blood Lactate Monitoring System
NOTE:
If the temperature is out of the operating range, the meter needs to be moved
to an area that is within the meter's operating range of 10°C to 40°C
(50°F
to 104°F). Measurement outside the temperature range will affect
accuracy of test result.
THE EDGE
25
THE EDGE
Blood Lactate Monitoring System
26
NOTE:
• DO NOT touch the target area of the test strip.
• DO NOT smear the blood drop onto the target area.
• DO NOT add or apply a second drop of blood. This
may cause false result.
• DO NOT proceed testing if the yellow window is
not full of blood sample. Insufficient blood sample
may cause inaccurate test result.
Step 4: The screen will show timing bars “----“, and the bars will then flash and
gradually diminish for countdown.
Step 5: After the timing bars disappear (approximately 45 seconds), the screen
will display test result.
• The test result is automatically stored in memory.
• Record test result in the personal Log Book.
Step 6:Remove the used test strip. The LCD screen on the meter will show the
code mumber and a flashing arrow next to the test strip icon, indicating
the meter is ready for another test.
Step 7: If more tests are to be performed, repeat steps 1 through 5.
Do not reuse test strips and lancets. Used test strips and lancets should be
treated as biological waste and dispose of properly.
Understanding the Test Result
Expected blood lactate levels for:
• Normal Range: 9-45 mg/dL(2-5 mmol/L).
• Higher Range: 45 mg/dL to 89.1 mg/dL( 5 -9.9 mmol/L ) should be
considered as severe hyperrlactatemia.
Blood Lactate Monitoring System
IMPORTANT:
THE EDGE
NOTE:
The measurement done outside the temperature range will show the test result
with a flashing symbol of thermometer
.
If the result is higher than 45 mg/dL, please contact your physician or
healthcare professional immediately.
• Anaerobic threshold (IAT): 22.5 -54 mg/dL About Muscle training.
27
THE EDGE
Blood Lactate Monitoring System
28
Using the Meter Memory
THE EDGE meter automatically stores up to 300 test results with date and
time. When more than 300 test results have been performed, the oldest result
will be dropped from memory each time a new result is added. When the test
results are recalled from memory, the most recent result is always displayed
first.
To view the results from memory:
Step 1: Press any key to turn on the meter and press the two buttons on the
meter simultaneously.
Step 2: A symbol of head " " will flash on screen. Press "ENTER" button to
view the latest result (with test date and time) in memory. Continue to
press the "SHIFT" button to view the previous results.
Step 3: Press the "SHIFT" and "ENTER" buttons simultaneously to exit viewing
memory.
Blood Lactate Monitoring System
Step 1: Press any key to turn on the meter.
Step 2:After the LCD screen shows a code number, unit of measurement, date
& time, and a symbol of test strip; press the two buttons on the meter
simultaneously to enter the Function Mode.
Step 3: A symbol of head " " will flash on screen. Press "SHIFT" button to skip
this selection.
Step 4: A symbol of cable " " will flash on screen. Press"SHIFT" button to skip
this selection.
Step 5: A symbol of speaker " " will flash on screen. Press "SHIFT" button to
skip this selection.
Step 6: A clock symbol " " will flash on screen. Press "ENTER" button to
enter setup of the date & time in the order of Year-Month-Day and then
Hour-Minute.
Step 7:The Year will flash on screen. Press "SHIFT" button to scroll through
the years and press "ENTER" button to confirm. Press and hold on
the "SHIFT" button for quick searching of the years.THE EDGE meter
provides calendar years from 2005 to 2099.
THE EDGE
Setting Time After First Use
29
THE EDGE
Blood Lactate Monitoring System
30
Step 8: The Month will flash on screen. Press "SHIFT" button to scroll through
the months and press "ENTER" button to confirm. Press and hold on
the "SHIFT" button for quick searching of the month.
Step 9: The Day will flash on screen. Press "SHIFT" button to scroll through
the days and press "ENTER" button to confirm. Press and hold on the
"SHIFT" button for quick searching of the day.
Step10: The Hour will flash on screen. THE EDGE meter uses am/pm time
clock. Press "SHIFT" button to scroll through the hours and press
"ENTER" button to confirm. Press and hold on the "SHIFT" button for
quick searching of the hour.
Step 11: The Minute will flash on screen. Press "SHIFT" button to scroll through
the minutes and press "ENTER" button to enter the correct minute.
Caring for THE EDGE meter is easy. Follow these simple guidelines to keep
THE EDGE meter working properly.
• DO NOT take THE EDGE meter apart. If there are technical problems or
questions in use of the meter, please call your authorized dealer.
• Handle the meter with care - severe shock, such as dropping the meter, could
damage the electronics.
• DO NOT try to clean the test strip holder.
• DO NOT contaminate the strip holder with blood or control solution.
Storage
• The meter is designed to be used within the temperature ranges between
10°C to 40°C
(50°F to 104°F).
• Avoid leaving the meter in extremely hot or cold places, such as near a heat
source or in an extremely hot or cold car.
• Do not store or use the meter or test strips where they may be exposed to
Blood Lactate Monitoring System
Precautions
THE EDGE
Caring for the Meter
31
THE EDGE
high humidity levels, such as in a bathroom or kitchen.
• Never immerse or hold the meter under running water.
Changing the Battery
Blood Lactate Monitoring System
THE EDGE meter operates on one 3V Lithium coin cell battery which should
maintain at least 1,000 blood tests. When the LCD screen displays a symbol of
“
”, this indicates the batteries are low and should be replaced as soon as
possible.
NOTE:
To save battery power, THE EDGE meter will turn off automatically after one
minute of non-use. All results stored in memory will be saved even if the meter
shuts off automatically. Remove the battery if unused for a long time.
To replace the battery:
Step 1: Open battery cover on backside of the meter.
32
NOTE: Dispose of used battery properly.
IMPORTANT:
You will need to reset time after replacing the battery. See P.29, “Setting Time
After First Use”.
Cleaning the Meter
To clean the outside of THE EDGE meter, use a lint-free cloth dampened with
soap water or alcohol.
NOTE:
DO NOT get water inside THE EDGE meter. Never immerse the
meter or hold it under running water. DO NOT use glass cleaners or household
cleaners on the meter.
Blood Lactate Monitoring System
Step 3:Replace the battery cover.
THE EDGE
Step 2:Remove the old battery from the battery
compartment and replace with a new one.
33
THE EDGE
Blood Lactate Monitoring System
34
Solving Problems
This section details the significant display screen messages and error codes
you may encounter when using THE EDGE Blood Lactate Monitoring System.
If you have further questions after reviewing these messages, call our
authorised dealer.essage Problem What To Do
Message “Code- - - -“
Problem The monitor has not been
coded with a code card.“
What To Do
• Insert the code card that
is included in the test strip
package into the code card
port on the top of backside
of the meter, and insert a
test strip into the test strip
holder at the bottom on the
front of the meter.
“Code ----“
Problem What To Do
• Insert a new code card from
a new pachage of test strips,
follow the procedures on p.14
"Coding the Meter".
• If problem persists, call the
authorized dealer.
The battery in the meter
is running out of power.
Replace the battery.
The temperature is out
of the meter's operating
range 10°C to 40°C (50°F
to 104°F) .
The meter needs to be moved
to an area that is within the
meter’s operating range, 10°C
to 40°C
(50°F to 104°F) .
Blood Lactate Monitoring System
The code card has been
damaged.
THE EDGE
Message 35
THE EDGE
Blood Lactate Monitoring System
36
Message Problem nt OK
• Monitor Checker result
fails.
• Used or defective test
strip
LO
The blood lactate result
is lower than 6mg/dL
(0.7 mmol/L).
HI
The blood lactate result is
higher than 200mg/dL
(22.2mmol/L).
What To Do
Repeat the test with a new
test strip. If problem persists,
call the authorised dealer.
Repeat the test to confirm the
test result. If the result is still
LO, contact your healthcare
professional.
Repeat the test to confirm the
test result. If the result is still
HI, contact your healthcare
professional.
Err
Problem The meter is damaged.
What To Do
Call the authorized dealer.
Blood Lactate Monitoring System
If you are unable to correct the problem after following the What To Do
procedures, call your authorised dealer in your country and/or contact your
healthcare professional with questions and concerns.
THE EDGE
Message 37
THE EDGE
Product Warranty
THE EDGE Blood Lactate Meter is guaranteed to be free of defects in
workmanship and materials under normal use for a period of five (5) years from
the date of purchase to the consumer.
Blood Lactate Monitoring System
The liability of Apex Biotechnology Corp is limited to repair or replacement
and in no event shall Apex Biotechnology Corp be liable for any collateral or
consequential damages or loss.
Instruments subjected to misuse, abuse, neglect, unauthorized repair or
modification will be excluded from this warranty.
This guarantee specifically excludes expendables and consumables.
All warranty claims must be directed to the Apex Biotechnology Corp
authorized dealer.
The warranty applies only to the original purchaser of the system.
38
Blood Lactate Monitoring System
Meter Type:
THE EDGE Blood Lactate Meter
Test Strips: EDGE Blood Lactate Test Strips
Test Range: 6 - 200 mg/dL (0.7 - 22.2 mmol/L)
Blood Source: Fingertip capillary whole blood
Sample Volume: Minimum 3μL
Reading Time: 45 sec
Hematocrit Range: 35 - 50%
Memory: 300 sets with date & time
Operating Temperature: 10°C to 40°C (50°F to 104°F)
Relative Humidity: Less than <85%
(Storage, Operating and Transportation)
Storage / Transport Condition: -20°C to 50°C (-4°F to 122°F) for meter
4°C to 30°C (39.2°F to 86°F) for test strip
Power Suppy: 3V Lithium coin cell battery
(CR2032, powered internal)
Dimension: 90Lx55Wx20H (mm)
Weight: 63 g
THE EDGE
Specifications
39
THE EDGE
Blood Lactate Monitoring System
40
Electromagnetic Compatibility: This equipment is complying with EMC
requirement of EN 60601-1-2
Classification according to IEC/EN 60601-1: IPXO, not evaluated as AP/APG equipment,
continuous operation.
Use-by date
Batch code
Temperature limit
Consult instructions for use
In vitro diagnostic medical device
Caution
Catalogue number
Keep away from sunlight
Do not re-use
Blood Lactate Monitoring System
THE EDGE
Symbols Used in this Manual
Manufacturer
Authorised representative in the European Community
41
THE EDGE
Blood Lactate Monitoring System
42
Supplies
S54108 THE EDGE Blood Lactate Monitoring System
S5638025 EDGE Test Strips 25's
S5638053 EDGE Test Strips 2 X 25's
S5800024 THE EDGE Lactate control solution
65235010002 Lancing Device
80050000003 Lancets (28G) 50's